Senior Quality Systems Manager - cGMP & eQMS

Energy Jobline ZR; Waunakee (WI); On-site; USD 110,000 - 190,000; Full time

Benefits offered by this job

Competitive compensation

Medical, Dental and Vision on Day 1

Life and AD&D Insurance

401k; advancement opportunities

Paid Holidays

Job summary

Join Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals located just outside Madison, Wisconsin in Waunakee. The On-Site QA Supervisor will lead the Quality System, including investigations, CAPAs, change controls, and regulatory compliance to support FDA/ICH and other pharma requirements.

Responsibilities include overseeing eQMS, product release, audit preparedness, and continuous improvement of cGMP Quality Systems, along with personnel training and workload

Qualifications

• Associate's or Bachelor's degree or higher required.
• 10+ years experience in QA; 15+ years preferred.

Responsibilities

• Manage Quality System functions including training, investigations, deviations, change controls, CAPAs and validation/qualification documents.
• Oversee procedures and documents; administer eQMS.
• Prepare and communicate Quality System metrics to management.
• Oversee external audits and responses to audit findings.
• Perform product release review and shipping documentation approval.
• Prepare Annual Product Review documentation for SPL marketed products.
• Draft and verify customer quality agreements and ensure SPL compliance.

Skills

Quality Assurance

Regulatory knowledge

Auditing

Education

Bachelor's degree or higher

Tools

eQMS system

Job description

Join Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals located just outside Madison, Wisconsin in Waunakee. The On-Site QA Supervisor will lead the Quality System, including investigations, CAPAs, change controls, and regulatory compliance to support FDA/ICH and other pharma requirements.

Responsibilities include overseeing eQMS, product release, audit preparedness, and continuous improvement of cGMP Quality Systems, along with personnel training and workload